WO2003075822A1 - Recipient de prelevement dote d'un element coulissant a avance automatique, pour matieres de remplissage liquides, de type suspension, visqueuses ou pateuses - Google Patents

Recipient de prelevement dote d'un element coulissant a avance automatique, pour matieres de remplissage liquides, de type suspension, visqueuses ou pateuses Download PDF

Info

Publication number
WO2003075822A1
WO2003075822A1 PCT/EP2003/001840 EP0301840W WO03075822A1 WO 2003075822 A1 WO2003075822 A1 WO 2003075822A1 EP 0301840 W EP0301840 W EP 0301840W WO 03075822 A1 WO03075822 A1 WO 03075822A1
Authority
WO
WIPO (PCT)
Prior art keywords
removal
sliding element
hollow body
membrane
container according
Prior art date
Application number
PCT/EP2003/001840
Other languages
German (de)
English (en)
Inventor
Werner Müller
Karl Karch
Hermann Koch
Hans-Joachim Ploss
Original Assignee
Aventis Pharma Deutschland Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aventis Pharma Deutschland Gmbh filed Critical Aventis Pharma Deutschland Gmbh
Priority to AU2003210339A priority Critical patent/AU2003210339A1/en
Publication of WO2003075822A1 publication Critical patent/WO2003075822A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/0005—Containers or packages provided with a piston or with a movable bottom or partition having approximately the same section as the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the invention relates to a removal container which allows liquid, suspension-like, viscous or pasty filling goods, in particular protein-containing injection preparations or pharmaceutical preparations of biotechnologically produced pharmaceutical substances, to be filled and removed in such a way that there is no air supernatant or the contact during storage and removal to the surrounding atmosphere is minimized.
  • the aim of the invention was now to develop a removal container which does not have the disadvantages mentioned above, i.e. a removal container, the z. B. actually contains no airspace, the injection preparation is drastically stabilized against physical stress, and in which, despite partial removal of the contents, the stability is maintained in the same way.
  • a removal container containing a filling material consisting of a) a hollow body, which b) is closed at one end by a sliding element and c) at the other end by a membrane attached to the hollow body, characterized in that the sliding element during the removal of the filling material through the membrane only by the air pressure acting on the sliding element.
  • the hollow body must be shaped in such a way that the sliding element can move in the container according to the amount removed.
  • the hollow body can take various cross-sectional shapes, such as. B. round or angular with rounded corners, preferably round.
  • the cross-sectional shape must be so constant over the entire useful length of the hollow body that the sliding element closes the hollow body securely. However, the cross-sectional area may twist over the usable length.
  • the line of movement of the sliding element in the hollow body does not necessarily have to be a straight line.
  • the hollow body can be formed from a wide variety of materials, e.g. As glass, aluminum, etc., glass is preferred. If necessary, the hollow body can also be tapered at the “membrane end”.
  • the sliding element can consist of various materials, such as. B. rubber, ceramic or plastic, preferably rubber. It must be shaped in such a way that it simultaneously slides freely in the hollow body, if appropriate after appropriate treatment of the hollow body and / or sealing element, and also tightly closes the hollow body.
  • the sliding element has a circumferential sealing element on its contact surface with the hollow body, which sealingly seals both elements.
  • This sealing element can be an integral part of the sliding element or additionally applied to it.
  • O-rings made of elastic, sealing material can be used, e.g. Rubber or teflon.
  • Piston plugs or ceramic pistons provided with a sealing element may be mentioned as examples of sliding elements; the piston plug is particularly preferably made of rubber.
  • the filling material is removed by piercing the membrane with a removal system.
  • removal systems for removal of the filling z.
  • B. syringes such.
  • the membrane must be able to seal itself again during and after removal.
  • elastic materials come into question such as. B. rubber or plastic, rubber is preferred.
  • the membrane can be positively connected to the hollow body by various fastening systems, such as. B. by means of a crimp cap, a union nut, by gluing, etc .; the crimp cap is preferred.
  • the size of the withdrawal container can vary widely. It depends on the desired amount of the filling and can, for. B. Volume ranges from 1 to 250 ml, such as 1, 5 ml, 1, 7 ml, 3 ml, 5 ml, 10 ml, 20 ml, 50 ml. Also larger or smaller volumes are conceivable. Withdrawal containers of size 5 to 20 ml are preferred, very particularly preferably 10 ml.
  • filling material such as, for. B. solutions or suspensions, preferably protein preparations or pharmaceutical preparations of biotechnologically produced drugs. Insulins and their analogs, growth hormones or antithrombotics are particularly preferred, insulins and their analogs are very particularly preferred.
  • the invention also relates to a method for removal from a removal container as described above, which is characterized in that the membrane is pierced with a removal system and the filling material is transferred into the removal system, the sliding element automatically moving upwards in accordance with the amount of filling material removed.
  • a removal container (1) is shown in section.
  • the hollow body (2) is closed at one end (3a) with the sliding element (3) and at the other end (4a) with a membrane (4).
  • the sliding element (3) is freely movable in the hollow body (2) in the direction of the end (4a).
  • the end (4a) is closed with a membrane (4) by means of a fastening system (5).
  • the filling material fills the removal container without any significant air overhang.
  • the membrane (4) is pierced.
  • the sliding element (3) moves in the direction of the end (4a) in accordance with the amount of filling material that is currently being removed. No or no significant amount of "non-sterile" air penetrates into the removal container.
  • Fig. 2 shows a partially emptied state of the removal container on average.
  • the reference numbers correspond to those in Fig. 1.
  • the physical stabilization was checked, for example, using an insulin preparation with an acidic pH.
  • a vibration test was used, an established method for the investigation of insulin aggregations after influence by physical stress (V. Feingold et.al., Diabetologia (1984), 27, 373-378).
  • the insulin preparation to be investigated is filled into a glass vessel with a volume of 2 ml (HPLC vial) once without and once with an air supernatant of 100 ⁇ l, in order to fill a full container with no air supernatant and the other time the air volume in a normal one Simulate multiple sampling bottle.
  • the bottles are placed in a bottle holder and fixed to a specially designed vibration system and loaded at 37 ° C (thermal load), a frequency of 40Hz and a deflection of 20G (mechanical load).
  • the vibration is generated by a kind of loudspeaker membrane, coupled to an amplifier with frequency and deflection controller.
  • the period of time until which the preparation remains clear can be regarded as a measure of the physical stability of insulin preparations.
  • To measure turbidity the vials are removed from the test system at different times and examined for the degree of turbidity.
  • 3 batches of an insulin preparation with an acidic pH were filled with 3 vials without air space and one with 100 ⁇ l air space and examined by means of a vibration test. While all vials in the 3 batches with air supernatant showed a clear turbidity after 24 hours, all vials in the 3 batches without air supernatant showed no turbidity even after 168 hours (after which the test was stopped) and were therefore stable.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Extraction Or Liquid Replacement (AREA)

Abstract

Récipient de prélèvement qui permet de prélever des matières de remplissage liquides, de type suspension, visqueuses ou pâteuses de manière telle qu'il ne reste pas d'air contenu au-dessus de la matière ou que le contact avec l'environnement ambiant est réduit à un minimum pendant le stockage et le prélèvement. Ledit récipient de prélèvement contenant la matière de remplissage est constitué d'un corps creux qui est fermé à une extrémité par un élément coulissant et à l'autre extrémité par une membrane fixée au corps creux. Lors du prélèvement de la matière de remplissage à travers la membrane, l'élément coulissant se déplace uniquement sous l'effet de la pression de l'air s'exerçant sur lui. La présente invention concerne en outre un procédé de prélèvement de la matière de remplissage.
PCT/EP2003/001840 2002-03-08 2003-02-24 Recipient de prelevement dote d'un element coulissant a avance automatique, pour matieres de remplissage liquides, de type suspension, visqueuses ou pateuses WO2003075822A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003210339A AU2003210339A1 (en) 2002-03-08 2003-02-24 Discharge container with an automatically following sliding element for liquid, suspension-type viscous or pasty filling items

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2002110095 DE10210095A1 (de) 2002-03-08 2002-03-08 Entnahmebehältnis mit selbsttätig nachrückendem Gleitelement für flüssige, suspensionsartige, viskose oder pastöse Füllgüter
DE10210095.0 2002-03-08

Publications (1)

Publication Number Publication Date
WO2003075822A1 true WO2003075822A1 (fr) 2003-09-18

Family

ID=27771098

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2003/001840 WO2003075822A1 (fr) 2002-03-08 2003-02-24 Recipient de prelevement dote d'un element coulissant a avance automatique, pour matieres de remplissage liquides, de type suspension, visqueuses ou pateuses

Country Status (5)

Country Link
AR (1) AR038745A1 (fr)
AU (1) AU2003210339A1 (fr)
DE (1) DE10210095A1 (fr)
TW (1) TW200400915A (fr)
WO (1) WO2003075822A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5230707A (en) * 1988-07-21 1993-07-27 Maurice Laderoute Limited use hypodermic syringe
FR2714824A1 (fr) * 1994-01-12 1995-07-13 Debiotech Sa Dispositif à carpule pour la distribution d'un liquide.
WO2000028941A2 (fr) * 1998-11-17 2000-05-25 Novo Nordisk A/S Dispositif de transfert

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5230707A (en) * 1988-07-21 1993-07-27 Maurice Laderoute Limited use hypodermic syringe
FR2714824A1 (fr) * 1994-01-12 1995-07-13 Debiotech Sa Dispositif à carpule pour la distribution d'un liquide.
WO2000028941A2 (fr) * 1998-11-17 2000-05-25 Novo Nordisk A/S Dispositif de transfert

Also Published As

Publication number Publication date
DE10210095A1 (de) 2003-09-25
AR038745A1 (es) 2005-01-26
AU2003210339A1 (en) 2003-09-22
TW200400915A (en) 2004-01-16

Similar Documents

Publication Publication Date Title
EP0235691B1 (fr) Dispositif pour l'administration de médicaments en suspension
DE69127614T2 (de) Spritzenzylinder mit zwei kammern
EP2723482B1 (fr) Dispositif destiné à mélanger et appliquer un produit ayant peu de bulles
DE69712499T2 (de) Abgabesystem für in pharmazeutischen phiolen verpackte arzneimittel
AT500930B1 (de) Verfahren und vorrichtung zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes
EP1915184A1 (fr) Contenant a deux chambres sans derivation dans le corps cylindrique
DE102005038497A1 (de) Doppelkammer-Behälter ohne Bypass
WO2007020239A1 (fr) Contenant a deux chambres et procede pour le remplir
DE102009041065A1 (de) Verschlussdeckel mit vorbefülltem Dosierzylinder als Verpackung von in Flüssigkeit zu lösenden Stoffen im Pharma- und Nahrungsmittelbereich
DE1491850B1 (de) Spritzampulle
DE2364414A1 (de) Zusatzstoff und verfahren zum herstellen von infusionsloesungen
DE69016350T2 (de) Arzneimittelabgabe- und Dosiervorrichtung mit einer doppelten Abgabeöffnung.
DE19927201A1 (de) Spritze für medizinische Zwecke
EP2371343B1 (fr) Dispositif de stockage et de dosage d'un solvant
DE2433440A1 (de) Eine einheit mit zwei abteilungen fuer nacheinander injizierbare, fluessige vitaminpraeparationen
DE69904630T2 (de) Beutel zum aufbewahren und transportieren von sterilen produkten in pulverform und zum herstellen von lösungen aus diesen produkten in diesem beutel
WO2003075822A1 (fr) Recipient de prelevement dote d'un element coulissant a avance automatique, pour matieres de remplissage liquides, de type suspension, visqueuses ou pateuses
EP0531257A1 (fr) Méthode et dispositif pour contenir et administrer une dispersion contenant des peptides
DE20221679U1 (de) Vorrichtung zur Konditionierung einer Oxaliplatinlösung
DE2331167C2 (de) Vorrichtung zum Mischen von in zwei getrennten Räumen enthaltenen Substanzen
DE2439975A1 (de) Gefaess fuer medizinische zwecke
WO2016055445A1 (fr) Système et procédé pour la préparation d'une injection
DE3324635A1 (de) Mehrzweckpackbehaeltervorrichtung
DE3024768A1 (de) Anordnung fuer die herstellung parenteraler naehrloesungen o.dgl
DE2433643A1 (de) Zweikammerbehaelter fuer pharmazeutische loesungen

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ OM PH PL PT RO RU SC SD SE SG SK SL TJ TM TN TR TT TZ UA UG UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PT SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP